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Application 021861

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PATANASEOLOPATADINE HYDROCHLORIDESPRAY, METERED;NASAL0.665MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0332PATANASEolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0078-0834PATANASEolopatadine hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0834PATANASEolopatadine hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
61314-320Olopatadine Hydrochlorideolopatadine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-320Olopatadine Hydrochlorideolopatadine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-320Olopatadine Hydrochlorideolopatadine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66749SUPPL2021-03-11
66550SUPPL2021-03-05
16475SUPPL2015-11-04
6327SUPPL2015-10-28
6326SUPPL2012-02-27
37779SUPPL2012-02-24
28731SUPPL2010-04-05
37778SUPPL2010-04-04
42330ORIG2010-03-19
28730SUPPL2010-01-26
37777SUPPL2009-12-02
37776ORIG2008-04-23
6325ORIG2008-04-22
53361ORIG1900-01-01
53360ORIG1900-01-01
53359ORIG1900-01-01
53358ORIG1900-01-01
53357ORIG1900-01-01
53356ORIG1900-01-01